Anesthesia Recovery PeriodNCT06332157
Postoperative Quality of Recovery After General Anesthesia With Remimazolam
A study testing Remimazolam besylate and Propofol Injection Emulsion in people with Anesthesia Recovery Period, run by Beijing Chao Yang Hospital.
Trial summary
126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Recovery Period
- What is being tested?
- Remimazolam besylate and Propofol Injection Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA was classified as I-II
- The operative time was less than 180 minutes
- Age ranges from 18 to 65 years
- Informed consent is signed by all study participants
Who cannot join
- Pregnant or lactating women
- Patients with Difficult Airways
- History of severe neurological and muscular diseases and mental retardation
- Patients with severe respiratory and circulatory diseases
- Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
- Urea or urea nitrogen ≥1.5×ULN, serum creatinine greater than the upper limit of normal
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- Take diazole drugs and/or opioids in one month or nearly three months
- Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
- Patients who could not monitor the depth of anesthesia for various reasons
Trial locations and contacts
No sites are listed yet.
Dongjiao An, master contact
About this study
Official title: Postoperative Quality of Recovery After Patients' Undergoing General Anesthesia With Remimazolam Compared to Propofol, A Randomized Non-inferiority Trial
126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.
Read the detailed description
This study was a randomized, single-blind, single-center, positive drug controlled, non-inferiority trial. According to the inclusion and exclusion criteria, 126 patients undergoing general anesthesia for elective non-cardiac surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. After the patient lost consciousness, routine analgesia and muscle relaxants were given, followed by tracheal intubation and mechanical ventilation. During the anesthesia maintenance phase, vital signs and depth of anesthesia were continuously monitored, sedatives and analgesics were continuously pumped, and muscle relaxants were added intermittently as needed. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.
- Conditions
- Anesthesia Recovery Period
- Being tested
- Remimazolam besylate, Propofol Injection Emulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
In Remimazolam group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min and maintained with 1.0-2.0mg/min until the end of surgery.
Propofol Injection EmulsionDrug
In Propofol group, anesthesia was induced with propofol injection emulsion at a rate of 2mg/kg and maintained with 6-8mg/kg/h until the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Anesthesia was induced by pump injection of remimazolam besylate at a rate of 6mg/min. Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Receives: Drug: Remimazolam besylate |
| Propofol group | Active comparator | Anesthesia was induced with propofol injection 2mg/kg intravenously. Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol injection. Receives: Drug: Propofol Injection Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
15-item quality of recovery scale
Patient-measured scales. It was composed of 15 items of five dimensions: physical well-being, physical independence, emotional state, psychological support, and pain. The scale is scored from 0 to 150. Higher scores indicate better quality of recovery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Recovery PeriodStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332157
- Sponsor's protocol ID
- 2023-ke-715-1
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Quality of Recovery After Patients' Undergoing General Anesthesia With Remimazolam Compared to Propofol, A Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06332157
- Acronym / sponsor ID
- 2023-ke-715-1
- Conditions
- Anesthesia Recovery Period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.
Detailed description
This study was a randomized, single-blind, single-center, positive drug controlled, non-inferiority trial. According to the inclusion and exclusion criteria, 126 patients undergoing general anesthesia for elective non-cardiac surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. After the patient lost consciousness, routine analgesia and muscle relaxants were given, followed by tracheal intubation and mechanical ventilation. During the anesthesia maintenance phase, vital signs and depth of anesthesia were continuously monitored, sedatives and analgesics were continuously pumped, and muscle relaxants were added intermittently as needed. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolam besylateAnesthesia was induced by pump injection of remimazolam besylate at a rate of 6mg/min. Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. |
| Propofol group | Active comparator | Drug: Propofol Injection EmulsionAnesthesia was induced with propofol injection 2mg/kg intravenously. Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA was classified as I-II
- The operative time was less than 180 minutes
- Age ranges from 18 to 65 years
- Informed consent is signed by all study participants
Key exclusion criteria (9 listed)
- Pregnant or lactating women
- Patients with Difficult Airways
- History of severe neurological and muscular diseases and mental retardation
- Patients with severe respiratory and circulatory diseases
- Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam besylateIn Remimazolam group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min and maintained with 1.0-2.0mg/min until the end of surgery. | Drug | Remimazolam group |
| Propofol Injection EmulsionIn Propofol group, anesthesia was induced with propofol injection emulsion at a rate of 2mg/kg and maintained with 6-8mg/kg/h until the end of surgery. | Drug | Propofol group |
Primary outcome
15-item quality of recovery scale
Time frame: 24 hours after surgery
Patient-measured scales. It was composed of 15 items of five dimensions: physical well-being, physical independence, emotional state, psychological support, and pain. The scale is scored from 0 to 150. Higher scores indicate better quality of recovery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongjiao An, master contact
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam besylate and Propofol Injection Emulsion in people with Anesthesia Recovery Period, run by Beijing Chao Yang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anshi Wu, doctor (010-85231330, wuanshi88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15-item quality of recovery scale (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.